Liposome technology has been utilized for drug delivery in clinical therapy and scientific research. To date, a handful of liposomal pharmaceutical formulations have been approved by the US Food and Drug Administration (“FDA”), and a number of new liposomal formulations are in clinical trials. However, the field of liposomal formulation is still evolving and each active pharmaceutical ingredient (“API”) presents unique challenges.
One area where liposomal formulations can be applied is in cancer APIs. For example, liposomal formulations of doxorubicin are presently available under the trade names Doxil® and Myocet®. Doxil® is a pegylated (polyethylene glycol coated) liposome-encapsulated form of doxorubicin formerly made by Ben Venue Laboratories in the United States for Janssen Products, LP, a subsidiary of Johnson & Johnson. Myocet® is a non-pegylated liposomal doxorubicin made by Enzon Pharmaceuticals for Cephalon in Europe and for Sopherion Therapeutics in the United States and Canada. Myocet® is approved in Europe and Canada for treatment of metastatic breast cancer in combination with cyclophosphamide, but is not yet approved by the FDA for use in the United States.
Despite the handful of approved liposomal pharmaceutical formulations, the field is still limited by the unique challenges and unpredictability of each different API, as well as the currently available methods of making liposomal formulations, which present difficult problems associated with scalability, low reproducibility, and product heterogeneity. There exists a need for improved liposomal formulations for use in drug delivery.